powder for oral solution

What Laxido Junior is and what it is used for

Laxido Junior contains macrogol 3350 and the electrolytes sodium chloride, sodium bicarbonate, and potassium chloride.

Laxido Junior is a laxative used to treat chronic constipation in children from 2 to 11 years. It is also used to treat an accumulation of hard stools in the intestine in children from 5 to 11 years which can be the result of prolonged constipation (this is called fecal impaction). Macrogol 3350 makes the baby’s stool softer and easier to get out, which relieves constipation. The electrolytes help maintain the body’s normal levels of sodium, potassium, and water while the baby is being treated for constipation.

What you need to know before giving Laxido Junior

Do not give Laxido Junior if your doctor has told your child:

  • is allergic to macrogol 3350, sodium chloride, sodium bicarbonate or potassium chloride
  • has a perforation (a wound) in the intestinal wall
  • have a blockage in the intestine
  • have intestinal paralysis (for example, your baby’s intestines may stop working due to bowel surgery or severe infection )
  • have ulcerative colitis , Crohn’s disease or toxic megacolon

If any of these apply to your child, talk to your doctor or pharmacist for further advice.

Warnings and cautions

Before giving Laxido Junior to your child for fecal impaction, your doctor should confirm that your child has this condition.

If your child has heart or kidney problems, decreased vomiting reflex, reflux esophagitis (heartburn caused by reflux of stomach contents to the esophagus), or decreased level of consciousness, you should talk to a doctor before giving Laxido Junior.

When your child takes Laxido Junior, the child should continue to drink a lot. The fluid in Laxido Junior should not replace your baby’s normal fluid intake.

Other medicines and Laxido Junior

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. Some drugs, e.g. antiepileptics (medicines used to treat epilepsy ), may not work as well if taken at the same time as Laxido Junior. When your child takes large amounts of Laxido Junior (eg in case of fecal impaction) your child should not take other medicines within one hour before and after taking Laxido Junior.

Laxido Junior with food, drink and alcohol

Food and drink do not affect the effect of Laxido Junior.

Pregnancy, breastfeeding and fertility

Laxido Junior can be given during pregnancy and lactation. Talk to your pharmacist or doctor before giving Laxido Junior.

Driving and using machines

Laxido Junior does not affect the ability to drive or use machines.

Laxido Junior contains potassium and sodium

This medicine contains 0.34 mmol (13 mg) potassium per bag. Take this into account if you give your child more than three bags daily and the child has impaired kidney function, or if the child is on a diet with controlled potassium intake.

This medicine contains 93 mg sodium (the main ingredient in table salt/table salt) per bag. This corresponds to approximately 4.6% of the highest recommended daily intake of sodium for adults.

How to give Laxido Junior

Always give this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. Laxido Junior should be taken orally (by mouth).

Chronic constipation

The recommended dose for chronic constipation depends on the age of the child and the response to treatment.

  • As a starting dose, 1 sachet should be given daily to children from 2 to 6 years and 2 sachets daily should be given to children from 7 to 11 years.
  • Your doctor may ask you to increase the number of sachets until your child has a soft stool.
  • If dose one needs to be increased, this should be done every other day. No more than 4 sachets per day are normally needed.

It is not necessary to take the whole drink at the same time, if your child prefers, half the drink can be taken in the morning and a half in the evening.

Fecal impaction

A treatment regimen with Laxido Junior looks like this:
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Number of sachets by Laxido Junior
Age (years) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
5 to 11 4 6 8 10 12 12 12

The daily number of sachets should be taken at different times. All doses should be taken within 12 hours (eg 08.00–20.00). Treatment can be stopped when the medicine has worked. This is shown by the fact that your child has large amounts of feces and/or watery diarrhea.

Instructions for mixing

To prepare Laxido Junior, dissolve the contents of a sachet in a quartz glass of water (62.5 ml). Stir well until all the powder is dissolved and the Laxido Junior solution is clear or slightly cloudy. Then let the child drink. If you want, you can add seasoning to the drink, e.g. orange juice. If your child takes Laxido Junior for fecal impaction, it may be easier to dissolve 12 sachets in 750 ml of water. In this case, the reconstituted solution must be stored by the relevant instructions in section 5.

Length of treatment

Chronic constipation

The treatment must last for a longer time, at least 6-12 months.

Fecal impaction

Your child may have severe pain and swelling in the abdomen, or vomiting or diarrhea. If this happens, consult your doctor or pharmacist. If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor, hospital, or the Poison Information Center (tel. 112) by mistake for assessment of the risk and advice.

Treatment with Laxido Junior can be up to 7 days.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If your child has any of the following side effects, stop taking Laxido Junior and contact a doctor immediately:

signs of a severe allergic reaction, e.g. difficulty breathing, or swelling of the face, lips, tongue, or throat

– signs of allergy e.g. rash, redness of the skin, hives, itching, or shortness of breath

– signs of change in the fluid or electrolyte levels in your child’s body, e.g. swelling (especially in the ankles), feeling tired, dehydration, or increased thirst with the headache. These symptoms may indicate that your blood potassium levels are higher or lower than normal.

The following side effects are most common:

– abdominal pain

– magkurr

– diarrhea

vomiting

– nausea

– tenderness in the anus (tail)

If your child is being treated for chronic constipation, diarrhea usually improves when a dose is reduced.

The following side effects are less common:

– swelling of your baby’s abdomen

– gases

– indigestion

Läkemedelsverket
Box 26
751 03 Uppsala

How to store Laxido Junior

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the sachet. The expiration date is the last day of the specified month.

Store unopened sachets at a maximum of 25 ºC.

Prepared Laxido Junior solution can be covered and stored in a refrigerator (2 ° C to 8 ° C), and should be used within 24 hours. After 24 hours, discard any unused solution.

Do not use this medicine if you notice that any of the sachets are damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration for Laxido Junior

The active substances in each sachet are macrogol 3350 (6.563 g), sodium chloride (175.4 mg), sodium bicarbonate (89.3 mg), and potassium chloride (25.1 mg).

Laxido Junior contains no other ingredients. It contains no dyes, flavors, or sweeteners.

What Laxido Junior looks like and the contents of the package

Laxido Junior is a white powder for an oral solution that is packaged in sachets.

Each sachet contains 6.9 g of powder and is packed in cartons containing 2, 6, 8, 10, 20, 30, 50, and 100 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

integral Pharma Ireland Limited

Finnabair Industrial Estate

Dundalk

Co Louth

A91 P9KD

Ireland

Manufacturer

Almac Pharma Services Limited

Almac House

20 Seagoe Industrial Estate

Craigavon

BT63 5QD

UK

Almac Pharma Services (Ireland) Limited

Finnabair Industrial Estate

Dundalk

Co Louth

A91 P9KD

Ireland

This medicinal product is authorized under the European Economic Area under the names:

Germany, Ireland, and the United Kingdom – Laxido Pediatric Plain

Portugal – Laxido Mini

Belgium and Luxembourg – Laxido Junior Neutral

Sweden – Laxido Junior

Muhammad Nadeem

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